A written law enacted by the legislature
Statute
A rule having the force of law issued by an ADMINISTRATIVE AGENCY
Regulation
Where are regulations found (Federal)? Indiana?
1. CFR (code of federal regulations)
2. IAC (Indiana administrative code)
Unsafe coloring agent or unsafe additive is an example of?
Adulteration
Directions when following are dangerous is an example of?
Misbranding
When are compounded drugs exempt from CGMP?
If the compound is for:
1. An individual patient
2. Based on the receipt of a valid prescription
3. Compounded by a licensed pharmacist or licensed physician
Pharmacies cannot compound and distribute more than (%) of total prescriptions dispensed or distributed
5%
Simplest device type that does not present unreasonable risk of illness or injury?
Class I
Examples of Class 1 devices?
Stethoscopes, scissors and toothbrushes
Devices that require special controls to assure the safety and effectiveness of the device?
Class II
- Need pre-market notification
Examples of Class II devices?
Syringes, tampons, condoms, hemoglobin A1C immunoassays
Devices that require premarket approval before marketing and are of substantial importance in preventing impairment of human health or presents a potential unreasonable risk of illness of injury?
Class III
Examples of Class III devices?
Pacemakers, replacement heart valves and soft contact lenses
All new devices automatically fall into this class unless FDA determines that they are substantially equivalent to other classes?
Class III
Currently the only BANNED device?
Prosthetic hair fibers
Examples of devices that require a prescription?
Contact lenses and diaphragms
FDA can require a manufacturer to recall a drug (T/F)?
False. Manufacturers can voluntarily issue a recall or can be requested by the FDA.
- Unless they go to the court
Gives Consumer Product Safety Commission authority to require special packaging of hazardous substances?
Poison Prevention Packaging Act
Testing requirements that a package must meet to be considered child resistant and qualify as special packaging?
1. At least 90% of adults should be able to open the container without significant difficulty
2. At least 85% of children under 5 who are not familiar with the packaging, should not be able to open the container in five minutes
3. At least 80% of children
Who can issue a waiver for non-child resistant packaging?
1. Prescribers can on a prescription-by-prescription basis
2. Patients or their representative can issue a blanket waiver for all their medications, or select ones.
Which drugs are exempt from special packaging?
1. Drugs that are not in a dosage form intended for oral administration (nasal sprays, eye drops and ointments)
2. Nitroglycerin
3. Isosorbide dinitrate
4. EES
5. Oral contraceptives
6. Cholestyramine/Colestipol powder/Colesevelam/ Sevelamer carbonate
7.
Who are package inserts for?
Healthcare professionals
Patient package inserts are required for these medications?
- Estrogens and oral contraceptives
- Written for patients
- Must be given on new and refilled medications
- In patient (Given initially then every 30 days) and outpatient
FDA-approved labeling written in patient friendly language that explains the uses, risks and precautions related to a particular drug?
Patient package insert
FDA-approved labeling written in patient friendly language that explains issues related to a specific drug or drug class?
Medication guide
Who requires Medication Guides?
1. Outpatients and not under the direct supervision of a healthcare professional
2. New and refilled medications
When are medication guides required?
1. The drug product is one for which patient labeling could help prevent serious adverse effects
2. The drug product is one that has serious risk/s (relative to benefits)
3. The drug product is important to health and patient adherence and directions for
Examples of medications that require medication guides?
NSAIDS, amphetamines and opioids
Parts of the PDMA?
1. Prohibits reimportation of a prescription drug in the United States (unless by the manufacturer, for an emergency, or by the patient for a max of 90 days)
2. Bans the actual or offer to sell, purchase or trade a prescription drug that was purchased by
Parts of the anti-tampering act?
1. Tampering or attempting to tamper with a product's packaging or labeling
2. Tainting a product
3. Communicating false information
4. Threatening to tamper
5. Conspiring to tamper
Pregnancy categories updated 2015?
1. Pregnancy
2. Lactation
3. Females and males of reproductive potential
Provides equivalency ratings for different products?
Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)
Pharmaceutical equivalents versus therapeutic equivalents?
1. Products with the same active ingredient, dosage form and strength
2. Likely have the same clinical and safety profile
A or B letters of Orange book represent pharmaceutical equivalence or therapeutic equivalence?
Therapeutic equivalence
- A: Bioequivalent and therapeutically equivalent
- B: Not bioequivalent and not therapeutically equivalent
Another term for IND and NDA process?
Drug Registration Process
Form a company must submit to the FDA for approval to begin clinical trials on a new drug?
Investigation new drug (IND) application
- Must submit an application for each clinical trial phase
A company can begin human trials if they have not received a rejection from the FDA within this time period after submitting their IND?
30 days
Which phases of clinical trial investigation use an IND application?
Phase I, II and III
This phase of clinical trial takes place in healthy volunteers?
Phase I
- Typically has less than 100 patients
In this phase of the clinical trial, the drug is introduced to patients with the disease evaluating the effectiveness of the drug and the short term side effects and risks associated with the drug?
Phase II
- Typically has less than 1000 patients
In this phase of clinical trial, additional information is gathered about the effectiveness and safety to evaluate overall benefit-risk relationship?
Phase III
A company can submit a NDA to the FDA for approval once this phase has been completed?
Phase III
How many days does the FDA have to respond to the NDA?
180 days
- Though often lengthy delays do occur, the manufacturers legally can take the FDA to court, though this typically does not occur.
Four different types of REMS?
1. Medication guides
2. Communication plans (~ PO/SL Fentantyl)
3. Elements to assure safe use (ETASU) (iPLEDGE)
4. Implementation system (Limited o Restricted Access to a medication)
Who is responsible for developing the REMS program for a drug or class of drugs?
The manufacturer
Pharmacies are exempt from FDA inspection per the FDCA unless?
The pharmacy manufactures, prepares or compounds drugs or devices
What data CANNOT be reviewed by DEA inspectors?
1. Financial data
2. Sales data
3. Pricing data
What is required for DEA inspections?
1. Credentials
2. Written notice of inspection
3. Required to state the purpose of their inspection
Situations in which the DEA DOES NOT need a search warrant or AIW?
1. Owner or PIC consents to the inspection
2. Imminent danger to the health and safety of the public
3. Emergency situations where obtaining a warrant isn't practical or situations where a warrant isn't constitutionally required
Search warrant vs. administrative inspection warrant?
1. AIWs have easier to satisfy requirements
2. AIWs have more restrictions
3. AIWs can only be served during regular business hours
Does the BOP need a warrant to inspect the pharmacy?
No, in Indiana you cannot resist inspections from the BOP and they can inspect without a warrant
The handling of hazardous drugs in healthcare settings?
USP 800
When is the ONLY time a schedule I drug can be manufactured, prescribed or dispensed?
When approved by the DEA for investigation purposes
What is the only difference between Federal and Indiana Law regarding scheduled substances?
All butalbital containing products are CIII in Indiana, whereas federally they are CIV
Extra activities that a DEA registrant can engage in without obtaining an additional registration?
Coincident activities
What is the only way to know for sure whether a DEA number is legitimate?
Verify on the National Technical Information Service (NTIS)
What must a practitioner require in order to use the institution's DEA number?
1. The prescribing must be done in the usual course of professional practice.
2. The individual is authorized by the state where the prescribing takes place.
3. The hospital has verified that the individual is authorized to prescribe.
4. The practitioner
Who is exempt from registering with the DEA?
1. Agent or employee who is registered to engage in a particular activity (e.g. Pharmacist or nurse)
2. Common or contract carrier or warehouseman (e.g. USPS, FedEx, UPS)
3. An ultimate user who possesses such substance for a lawful purpose (Patient)
4. O
Can schedule II substances in pharmacies and institutions be stored on shelves with non-controlled substances? Schedule I substances?
1. Yes, though must be dispersed throughout the stock of non-controls (Typically what is done with CIII-CV)
2. No, CI substances must be stored in a securely locked, substantially constructed cabinet
Storage requirement for control substances in practitioner's office?
All controlled substances must be in a locked cabinet
Requirements for inventories and records of all controlled substances?
1. Schedule I and II must be kept separately from all other records
2. C-III through C-V: Can be kept separately from all other records or in a way that information is readily retrievable from the ordinary business records of the pharmacy
T/F: Can an employee be hired if they have been convicted of a felony relating to controlled substances?
False.
- Though the registrant can request an exception if they:
1. Have a detailed description of the violation with supporting documents
2. Extent of the individual's potential access to controlled substances
3. Proposed safeguards to prevent diversions
How long should the records and reports of controlled substances be kept?
At least 2 years from the date of the record or inventory
What information should the pharmacy keep about the controlled substances dispensed?
1. Name and address of the patient
2. Date it was dispensed
3. Number of units or volume dispensed
4. Written or typewritten name or initials of the individual who dispensed or administered the substance.
Three file system vs. two file system of prescription storage?
1. CII (1 file), CIII-V (2 file), Non-control (3 file)
2. CII (1 file) CIII-V and non-controls (2 file)
Two ways in which a prescription is "readily retrievable" when using two-file system?
1. Red "C", no less than 1 inch high, stamped in the lower right corner on the face (front) of the prescription
2. Pharmacy's computer system identifies prescriptions by rx #
What records CANNOT be maintained at a central location?
1. DEA order forms (222)
2. Inventories
3. Prescriptions
Pharmacies can start maintaining records at a central location if not denied within how many days from the DEA?
14 days
What must be done if a pharmacy wants to keep certain records at a central location?
- Notify the DEA in writing, and include the following:
1. Nature of the records be kept
2. Exact location
3. Name, address, DEA # and type of DEA registration of the registrant
4. Whether those records will be maintained in a manual or computer readable
What is an acceptable records of receipt for CIII-CV?
The invoices sent by the supplier as long as there is a date and the controlled substances are easily identified.
What cannot be changed on a 222 form?
1. Serial numbers
2. Name, address, DEA #
3. Authorized activities
4. Schedules that can be handled
Maximum number of 222 books that can be kept at one time?
6
How should the Power of Attorney sign?
Roberta Registrant by Frieda Pharmacist, Attorney in Fact
Steps in filling out a 222 hardcopy?
1. Use only a typewriter, pen or indelible pencil
2. Only one item per line (Include the drug name, strength, package size, and quantity requested)
3. Write the number of lines completed
5. Write the name and address of the supplier (Only can have 1 suppl
What must the supplier do with the 222 form?
1. Record the date and how many containers were sent to the pharmacy
2. Keep Copy 1 and send Copy 2 to the DEA
When must Copy 2 be sent to the DEA?
By the close of the month
What happens if a supplier cannot fill the entire order when received?
They can partially fill it, and have up to 60 days to fill the balance, after 60 days the order form is no longer valid
Who can sign DEA form 222 when ORDERING?
The registrant or the person given POA
What must the purchaser record on DEA form 222 after RECEIVING drugs?
The date received and number of containers of each item received
What happens if a DEA form 222 is lost before the order is filled?
Purchaser must execute a new form identical to the first and send copy 1 and 2 to the supplier along with:
1. A statement about how the drugs were not received
2. The serial number of the lost form
3. The date of the lost form
While copy 3 is attached to
What is required if an UNUSED DEA form 222 is lost/stolen?
#NAME?
What happens if the purchaser realizes one of the items on the order form 222 is not needed after sending to supplier?
The purchaser can notify the supplier IN WRITING that some or all of the order is not needed
- The supplier can then draw a line through the canceled item and write "canceled" in the spot for quantity.
- Same thing that the supplier would do if a drug on
Can a supplier sign over a DEA order (form 222) to another supplier?
Yes, but must endorse the ENTIRE ORDER
Difference in the electronic 222 form?
1. Can order any schedule of drugs (Controlled and non-controlled)
2. Purchasers must include a unique number to track the order
3. The supplier cannot endorse electronic orders
What control substances are considered to be "on hand?
1. Possession of or under the control of the registrant (pharmacy, like emergency kits)
2. Substances returned by a customer
3. Invoiced to the pharmacy
4. Waiting areas/bins ready for a patient to pick up
How many inventories are there and what is required with each?
1. Initial inventory taken the day the registrant first engages in dispensing control substances
2. Biennial inventory which is taken every two years after the initial inventory
3. Inventory of newly scheduled drugs taken on the date it becomes a schedule
When is biennial inventory taken, and what must be included?
- On any date within two years of the last biennial inventory either at the opening of business or close of business (Stated if done at the opening/closing)
- Name of the drug, dosage form, strength, number of loose units and full containers
For the biennial inventory, which medications have to be counted exactly, and which can be estimated?
Exact:
- CI
- CII
- CIII-CV in a bottle with >1001 tablets/capsules
Estimated:
- CIII-CV in a bottle <1000 tablets
Can practitioners prescribe narcotics for the purpose of maintenance or detoxification purposes?
No, may only administer or dispense directly
What are the exceptions to maintenance and detoxification treatment?
1. If the practitioner is separately registered with DEA as a narcotic or opioid treatment program
- Can administer or dispense directly any schedule of drug to maintain or detoxify (CANNOT PRESCRIBE)
- Example: Methadone clinics
2. If the practitioner di
Drug Addiction and Treatment Act of 2000
Allows office based detoxification treatment of opioid dependent patient by allowing a practitioner to administer or dispense, including PRESCRIBE, any schedule III, IV or V narcotic drug specifically for use in maintenance and detoxification treatment
Requirements for prescribing narcotics for use in maintenance and detoxification treatment?
1. Prescriber must be a data waived physician
2. DEA number X
3. Drugs must be approved and in CIII-V (currently only buprenorphine and buprenorphine/naloxone combinations)
4. Physicians cannot treat more than 30 patients in first year and may treat up to
Two situations in which a pharmacy or other dispenser may distribute controlled substances to another practitioner or registrant?
1. Distributing to a practitioner who wants to dispense the medication to their patients and the number of dosage units doesn't exceed FIVE PERCENT of total number of dosage units of all CS distributed and dispensed in the same calendar year
2. A practiti
What is a reverse distributor?
Accept control substances for destruction
What form is needed for disposal of control substances?
DEA form 41
What should the pharmacy do if it exceeds five percent of all CS distributed?
Register as a DISTRIBUTOR
Four ways to dispose of control substances?
1. Sending to reverse distributor by contract carrier
2. Destroying the substances based on current laws
3. Send CS back in case of return or recall
4. Transporting CS by own means to person authorized to destroy
Who is notified when there is a theft of controlled substances?
The DEA must be notified immediately
Who is notified when "significant loss" of CS has occurred?
DEA and Indiana BOP
What form is used for CS theft/loss?
DEA form 106
The "big four
1. Physicians
2. Veterinarians
3. Podiatrists
4. Dentists
Additional practitioners with prescribing authority in Indiana?
1. Advanced practice nurse (NP, certified nurse midwives, clinical nurse specialists)
2. Physician assistant
3. Optometrist
APN prescribing requirements in Indiana?
1. Must work under a supervising practitioner
2. Can only prescribe within the scope and specialty of the practitioner (MD/DO, Dentist or Podiatrist)
3. Must have DEA # and Indiana CSR
4. Pharmacists in Indiana can ONLY fill prescriptions for APNs license
PA requirements for prescribing in Indiana?
1. Mid-level practitioners who work DIRECTLY under a supervising physician
2. Can only prescribe within the scope and specialty of the physican
2. NOT ALLOWED to do ANYTHING with schedule I substances
3. Must have DEA # and Indiana CSR
4. Must have at lea
Optometrists prescribing requirements in Indiana?
1. Mid-level practitioner allowed to practice INDEPENDENTLY WITHOUT a supervising physician
2. Allowed to prescribe medication based on a FORMULARY (currently any legend drug for treatment of the eye or associated structures)
3. Must have DEA # and CSR if
Indiana Requirements for CS prescriptions?
1. Full Name of the patient
2. Address of the patient
3. Date of issuance
4. Manual signature of the prescriber
5. Name, address, license number of prescriber
6. DEA number of prescriber
7. Drug NAME and STRENGTH/SIZE. DOSE , and QUANTITY
8. Directions fo
Which prescriptions can be prepared, called in, or faxed by an agent if authorized by the prescriber?
All prescriptions
Which prescriptions must be sent by the practitioner themselves and cannot be sent by an agent?
Electronic prescriptions
Drug order requirements in institutions?
1. Name and bed # of patient
2. Name and strength/size of drug
3. Amount to be dispensed
4. Adequate directions for use
5. Name of practitioner
What changes CANNOT be made to a schedule II prescription?
1. Patient's NAME
2. CS PRESCRIBED
3. Prescriber's SIGNATURE
**
ISSUE DATE MAY BE ADDED OR CHANGED AFTER SPEAKING TO PRESCRIBER IN INDIANA
**
Indiana Labeling requirements?
1. Date of filling
2. Dispensing pharmacy name, address, PHONE NUMBER
3. Serial # of rx
4. Name of patient (species of animal and owner name)
5. Name of prescriber
6. Directions for use and cautionary statements
7. Name of drug
Labeling requirements for a patient being discharged in an institution?
1. Date
2. Institutional pharmacy name, address and phone number
3. Serial #
4. Name of patient
5. Name of prescriber
6. Directions for use
7. Name of drug and STRENGTH
8. ROUTE of administration
9. PRECAUTIONARY INFORMATION
Exceptions to central fill label?
1. No more than a 7-day supply of a schedule II substance dispensed at one time for administration in an institution
2. No more than a 34-day supply or no more than 100 dosage units of schedule III-V substance dispensed at one time for administration in a
Labeling requirements for drug orders intended for use in the institution?
1. Patient identity
2. Patient location
3. Drug name
4. Drug strength
5. Route of administration
6. Quantity
7. Pharmacist's initial
Label requirements for unit dose packaging in the institution?
1. Drug name
2. Drug strength
3. Control # and/or expiration date
How many refills on a CIII-CV?
Only 5 and it expires 6 months from when it was written
How many refills on a CII?
None, and it expires one year from when it was written
When MUST the quantity dispensed be contained on a refill prescription?
If the quantity dispensed is something other than the original quantity authorized on the rx
When can a prescription be dispensed for a 90-day supply when the original rx was written for 30-day supply?
1. At the patient's request ONLY after the patient has been on the medication for at least 30 days
2. Control substance prescriptions cannot be dispensed for a 90-day supply
How many days supply can a prescriber write for a schedule II substance rx?
The prescriber can write enough prescriptions to receive up to a 90 day supply
- This can be on multiple prescriptions, though those prescriptions need directions on when they can be filled, no POST DATED!
When can a pharmacist can partially fill a CII prescription in Indiana?
1. Cannot provide the full amount and MUST provide remaining portion within 72 hours of first partial filling
2. LTC patient or terminal illness in which a pharmacist must document "terminally ill" or LTCF patient" on the prescription and can partially fi
What three requirements MUST be met in order for an emergency CII rx to be taken orally?
1. The immediate administration is necessary for proper treatment AND
2. There is no appropriate alternative available AND
3. It is not possible for the prescriber to provide a written prescription prior to dispensing
What is the maximum amount of a CII substance that can be prescribed for an emergency period?
Should only be an amount sufficient to treat the patient during the emergency period
Within how many days must the "cover prescription" for an emergency CII rx be delivered to the pharmacy? What phrase must the "cover prescription" contain?
1. The covering prescription must be delivered or postmarked within the 7-day period
2. Must contain "Authorization for Emergency Dispensing
Who must the pharmacist notify if the cover prescription for an emergency CII rx is not received within 7 days?
The nearest DEA office and the Indiana BOP
When can a fax prescription serve as the original?
1. For all non-control substances
2. For all CIII-V substances
3. Injectable schedule II narcotic substances for the direct administration to a patient
4. Prescription written for a CII substance for a resident of a LTCF
5. Schedule II narcotic substance
Are electronically signed faxed prescriptions acceptable for control substance prescriptions?
No, MUST be MANUAL signature of the prescriber
Additional criteria for controlled substances to be faxed?
1. Contains: date, full name, address of patient, address, license number, DEA # and manual signature of the provider, name, strength dosage, quantity of drug, directions, number of refills
2. Name and address of the pharmacy
3. Name of person transmittin
What must occur to fax a schedule II substance prescription?
Original, written, signed rx MUST be presented to pharmacist prior to ACTUAL DISPENSING
How many times can a legend rx be transferred? Controls?
1. Any number of times during the life of the prescription
2. ONLY once for CIII-V unless sharing same database
What information does a receiving pharmacist need in a transfer?
1. All the information on the prescription
2. Date of issue
3. Original number of refills
4. Remaining refills and last fill date
5. Date of original dispensing
6. Pharmacy name, address, DEA #, Rx #
7. Name of the pharmacist
What information does a transferring pharmacist need in a transfer?
1. Date of transfer
2. Pharmacy name, address, DEA #
3. Name of pharmacist
Types of sanctions?
1. Revocation
2. Suspension
3. Probation
4. Letter of reprimand and censure
5. Fine
What is a summarily suspension?
- "Emergency suspension"
- Done when a practitioner is a clear and immediate danger to the public
- Can be issued for 90 days, though renewed as many times as needed
- Physicians, veterinarians and PAs have to be notified about the allegations and the hea
When can you apply for a new license after revocation? What is required?
1. Seven years from date of revocation
2. Re-take all exams and any new license will be issued under a new number
Letter of reprimand versus censure?
1. Written record that a license has been disciplined and what specifically the board found inappropriate
2. A verbal expression of disapproval
A fine may not exceed this amount per violation?
1000 dollars except for incompetence due to physical or mental disability
A probationary license may include?
1. Reporting regularly to board
2. Limiting practice
3. Continuing education
4. Community service
5. Perform or refrain from performing an act
What prescriptions CANNOT be prescribed to a patient via telemedicine?
1. Abortion inducing drug
2. Ophthalmic device (glasses, contact lenses, low vision devices)
3. Opioid (Unless it is a partial agonist used to treat or manage opioid dependence.)
Which practitioners can utilize telemedicine in IN?
1. Physicians
2. Podiatrists
3. PAs
4. APNs
5. Optometrists
No Vets or dentists, all other practitioners can
What conditions must be met in order to prescribe a controlled substance through telemedicine?
1. Prescriber has a valid controlled substance registration
2. The patient has been seen by an IN HCP who has established a treatment plan to assist the telemedicine practitioner in the diagnosis of the patient
3. The prescriber has reviewed and approved
What must an OUT OF STATE telemedicine provider obtain prior to issuing prescriptions for a patient who RESIDES IN INDIANA?
A certification through IPLA that must be renewed when they renew their license
When prescribing opioids for a patient for the first time or for a child under the age of 18, what must the prescriber do?
- If prescribed by that provider for the first time or if for a child: The initial prescription should be limited to 7 days
- This does not apply if the prescription is issued for:
1. Cancer
2. Palliative Care
3. Treatment of a substance use disorder
4. C
When prescribing an opioid for the first time to a patient or if it is for a child, and the provider wants to prescribe more than the 7 day supply, what should be done?
- If the provider determined that a drug other than an opioid is not appropriate or it is in the professional judgement of the provider:
- They shall document it in the patient's medical record the indication or that the prescriber is using their medical
Can pharmacists partially fill an opioid?
#NAME?
For which practitioner can pharmacists not substitute for a generic if written for a brand name product?
#NAME?
What two signature lines MUST an Indiana prescription have?
1. Left side "Dispense as written"
2. Right side "May substitute"
**
Does not apply to electronic prescriptions or prescriptions taken orally in a pharmacy
**
What MUST a prescription have for Indiana Medicaid patients when the brand is required?
Prescriber must write "Brand Medically Necessary" in own handwriting
For IN Medicaid patients, can a provider want a brand name if the prescription is sent electronically?
- Yes, but it must have "Brand Medically Necessary" on the prescription.
- If the provider gives a verbal instruction, they must send a written/electronic prescription with "Brand Medically Necessary" on it.
What must a prescription have if a generic is substituted for the brand?
1. Both products (___generic for ___)
2. Name of manufacturer, distributor or both for actual product dispensed either on the prescription or in an electronic format for each refill.
Requirements for substituting biological products?
1. Interchangable by the FDA
2. Practitioner signed "may substitute"
3. Inform patient of substitution
4. Must notify the practitioner within 10 days of the name and manufacturer of the biologic product dispensed (Not needed if a dispensed refill has not
Anabolic steroids CANNOT be prescribed for?
1. Enhancing performance in an exercise, sport, or game
2. Hormonal manipulation to increase muscle mass, strength, or weight without a medical necessity
What are the requirements to have a medical device in an institution?
1. The institution's pharmacy holds an IN pharmacy permit OR it if it is held in a remote area under the jurisdiction of the board OR if the device is in a licensed health care facility
2. Operated under the direct supervision and control of a pharmacy or
Retrospective, current or prospective review by a pharmacist of a patient's drug related history
Drug regimen review
A program designed to measure and assess on a retrospective and prospective basis the proper use of drugs?
Drug utilization review
What is missing from the Indiana prescription requirements that is required on a "prescription?
Date of issue
The pharmacist who will qualify the pharmacy by being responsible to the board of legal operations of the pharmacy under the permit?
Qualifying pharmacist
How many members does the BOP consist of? How many pharmacists and non-pharmacists?
1. Seven members
2. SIX pharmacists and ONE non-pharmacist
BOP members must be from various practices but one MUST be a pharmacist in what setting?
A hospital pharmacist
How many people on the BOP can be from the same political party?
Maximum of four people
What are the duties required that the BoP must do?
1. Establish standards for the competent practice of pharmacy
2. Establish standards for a pharmacist to counsel individuals
3. Establish procedures for returning expired drugs
4. Adopt rules and procedures regarding the electronic transmission of prescri
What must the BOP do upon discovery of impaired pharmacists?
1. Must assist in rehabilitation
2. Can make arrangements and support groups who identify and assist these pharmacists
3. Must keep all information confidential
**
Currently the board supports the Pharmacist Recovery Network of Indiana which has a contrac
When is the ONLY time the confidentiality of impaired pharmacists with PRNIndiana can be broken?
1. If the pharmacist is non-compliant with the rehabilitation program
2. Danger to themselves or others
In what situations MUST PRNIndiana immediately report the impaired pharmacist to the board?
1. Pharmacist constitutes an imminent danger to the public or themselves
2. Refuses to cooperate with the program
3. Refuses to submit to treatment
4. Impairment is not substantially alleviated through treatment
Who is responsible for supervising interns?
#NAME?
What three things must give the BOP to be ELIGIBLE for pharmacist licensure?
1. At least 18 years old
2. Don't have a conviction that would have a direct bearing on ability to practice
3. Graduated with a degree from ACPE or program approved by the board
Acceptable practice experience time for interns/externs?
Not less than four and not more than sixty hours per week
Minimum hours of practical experience for interns/externs under the supervision of a pharmacist?
1500 hours
Pharmacists wishing to transfer their license to the state of Indiana will have to take the naplex or similar exam if they haven't been actively practicing in this time period?
Last twelve months
Difference between an active and inactive license?
#NAME?
What must be done in order for an inactive pharmacist to reactivate their license?
1. Meeting current CE requirements
2. Successfully demonstrating your ability to actively practice to the board
*
Must get the 30 hours + all CE that should have been done while you were inactive
*
When does a pharmacist license expire in Indiana?
Biennially on June 30 of even numbered years
Three exceptions for NOT keeping patient information confidential?
1. Best interest of the patient
2. Requested by the board, its representatives or law enforcement
3. Criminal prosecution or proceeding
Can a pharmacist refuse to honor a prescription?
- A pharmacist has a duty to honor all prescriptions, though can refuse if it would:
1. Be contract to the law
2. Be against the best interest of the patient
3. Aid or abet an addiction or habit
4. Be contrary to the health and safety of the patient
When is the only time a pharmacy technician can release patient information?
In connection with a criminal prosecution or proceeding
Pharmacy permit categories?
1. Category I: retail pharmacies that dispense drugs to the general public
2. Category II: Institutional pharmacies (hospitals, clinics, health care facilities, nursing homes, etc.)
3. Category III: Closed door pharmacies that are not open to the general
Requirements for pharmacy permit application?
1. Name and occupation of person desiring permit
2. Location of the pharmacy (street address and city)
3. Name of qualifying pharmacist
What is required when applying for more than one pharmacy?
1. A separate application for each location
2. Each pharmacy must have a different qualifying pharmacist
Circumstances in which a pharmacist can serve at more than one category II pharmacy as the qualifying pharmacist?
1. The permit holder has made a reasonable effort to obtain another qualifying pharmacist
2. The single pharmacist could effectively fulfill all duties and responsibilities at both locations
What additional information needs to be submitted to the BoP in order to obtain a permit?
- Besides the name/occupation, location and name of qualifying pharmacist:
1. Individuals that will be practicing pharmacy at that location and the number of hours each week that the pharmacy will be open to the public
2. A sufficient stock of emergency a
The board may grant or deny an application for a pharmacy permit within this time period?
120 days after the application
Requirements of pharmacy?
1. Stationary
2. Sufficiently secure
3. Well lighted and ventilated with clean and sanitary surroundings
4. Equipped with a sink
5. Prescription filling area
If the board requires additional equipment for a pharmacy permit, how many days does the pharmacist have to make sure equipment is retained?
30 days from notification of board
Maximum pharmacist:technician ratio?
1:6
- This now includes interns
What is the maximum number of technician in training that one pharmacist can supervise?
3 of the 6
Requirements for pharmacy to stay open when pharmacist is absent?
1. All legend drugs and other merchandise securely locked
2. Sign 20 X 30 inches displayed stating "Prescription Department Closed, No Pharmacist On Duty"
3. Only pharmacist has access to secured area
Are pharmacy permits transferable?
No, new owners must apply for a new permit
If transferring ownership, an application must be submitted no later than?
10 days after change of ownership
Does a pharmacy need a new permit if it changes location?
Yes
The board must be notified by the permit holder if the pharmacy closes for more than how many days?
Five consecutive days or more
Requirements for permanently closing pharmacy?
1. Notify board at least 20 days before transfer of CS (Include a copy of the inventory form and the name, address and DEA # of the person the drugs will be transferred to)
2. Remove all legend drugs (By returning, transferring, or destroying them)
3. Ins
All original prescriptions must be maintained for how many years?
At least two years
How must original prescriptions be maintained?
In a numerical and chronological order
Requirements for refilling a prescription w/out prescriber authorization?
1. Reasonable effort to contact prescriber
2. Not providing medication would be detrimental to patient's health
3. The original prescription had authorized refills (either all used or expired)
4. Prescription was last filled at your pharmacy or same chain
What is the required documentation for refilling a prescription without authorization from a prescriber?
1. Record the dates and times that the pharmacist attempted to contact the prescriber
2. The fact that the pharmacists dispensed the fill without authorization
3. Date of the refill
4. Quantity refilled
5. Dispenser's identify on the original prescription
What information must be kept for prescription records?
1. Name and dosage of the drug
2. Date of each fill
3. Quantity dispensed
4. Identity of the pharmacist
5. Total number of refills.
How many emergency refills are allowed for the same prescription?
Only one
Can prescriptions for control substances be emergency refilled?
NO
Requirements for reuse of medications?
1. If dispensed to individual in institutional facility, hospice program or county jail/correction facility
2. Properly stored and securely maintained
3. Unopened and returned in original container or unit dose package
4. Returned to same pharmacy where d
Can pharmacist fill a prescription after the demise of a practitioner?
No, unless it is in the best interest of the patient's health
Can a pharmacist fill a prescription after the demise of a patient?
No
What pharmacies are allowed to reuse control substances?
Category II pharmacies
Which vaccines can pharmacists administer in Indiana?
1. Influenza
2. Shingles
3. Pneumonia
4. Tetanus, diptheria and acellular pertussis (Tdap)
5. HPV
6. Meningitis
7. Varicella
8. Hepatitis A
9. Hepatitis B
10. Measles, Mumps, and Rubella (MMR)
11. Haemophilus influenza type b (Hib)
Who can we provide immunizations for under a protocol?
Only those 11 years of age and older except pneumonia (at least 50 years of age)
When must the prescriber be notified after providing the immunization?
The prescriber and primary care physician must be notified within 14 days after immunization
Can a pharmacist administer a vaccine upon a written order prescribed by an OUT OF STATE physician?
No, must be practicing in Indiana
What must be included in the protocols for administering vaccines?
1. Name and strength of the vaccine
2. Precautions and indications
3. Intended audience or patient population
4. The appropriate dosage
5. Administration schedule in accordance to the CDC
6. Appropriate route of administration
7. Appropriate injection sit
Who does the pharmacist report to in the case of an adverse event associated with a vaccine?
1. The prescriber and primary care physician within 72 hours
2. VAERS
What courses must a pharmacist complete in order to provide immunizations to patients?
1. Immunization course from ACPE
2. CPR training certification
CE biennium?
January 1 of even numbered years to December 31 of odd numbered years
CE requirements each biennium, and how long must the CE records be retained?
1. 30 hours
2. Maximum of 6 (1/5) hours of business, management, or computer-related
2. At least 24 (4/5) hours must be pharmacy practice related
3. At least 15 (1/2) hours must be from ACPE accredited/sponsored CE programs
4. Keep records for at least 4
Do you have to complete all CE hours if licensed DURING a biennium?
No, if licensed more than 6 months during biennium, required to complete 1.25 hours of CE for each month or part of month you were licensed
**
If licensed less than 6 months in the biennium, no CE is required during that biennium
**
Where does a consultant pharmacist practice?
LTC facility or other residential patients
What is a "Performance improvement program?
It is a continuous, systematic review of key medication use processes to identify, evaluate, and improve medication use and patient care.
The pharmacist who directs the activities of the INSTITUTIONAL PHARMACY and responsible for all activities of the INSTITUTIONAL PHARMACY?
The "pharmacist in charge
The pharmacist who accepts responsibility for the operation of a pharmacy and whose name is listed on the pharmacy permit?
The "qualifying pharmacist
Inappropriate provision of pharmaceutical services whether or not resulting in an adverse health incident
Quality related event
Difference between a temporary and reversible condition?
#NAME?
Quality related events should be reviewed at least how many months as part of the policies and procedures manual?
At least every three months
Pharmacists are responsible for checking all drug orders within a maximum of what time frame when practicing in an institutional pharmacy?
Within a maximum of 24 hours
Requirements for the drugs that are in the cabinets?
1. Properly labeled
2 Only prepackaged in amounts sufficient for immediate requirements not exceeding 24 hours
3. A record is made when drugs are used
4. All drugs are reviewed by a pharmacist when they return to duty
If a supervisory licensed nurse removes drug(s) from the pharmacy when there is no pharmacist there, what must be done?
The nurse should record the following:
1. Name of the drug
2. Drug strength
3. Amount taken
4. Date
5. Time
6. Signature of the nurse
7. Copy of the order should also be left
Must be needed to treat the immediate needs of a patient
How can medications be obtained in an institutional setting when the pharmacy is CLOSED or the pharmacist is ABSENT?
1. Cabinets
2. Supervisory nurse authorized access to pharmacy
3. Emergency boxes, kits, or drug carts
How many pharmacies can the drugs from an emergency kit come from?
Only one supplying pharmacy
How should the exterior labeling of an emergency kit be?
1. Drug name
2. Drug size or strength
3. Quantity included
4. Expiration date of the kit
How should the drugs within the emergency kit be labeled?
1. Drug name
2. Drug size or strength
3.
Name of the manufacturer, packer or distributor
(Difference between interior and exterior labeling)
4. Lot number
5. Expiration Date
What should the nurse record when the emergency kit is used?
1. Patient name
2. Drug name
3. Strength of the drug
4. Quantity removed
5. Date of removal
6. Time of removal
Labeling requirements for medications dispensed for use in institutional facility?
1. Patients identification and location
2. Brand/generic name or both
3. Strength of drug
4. Route of administration
5. Quantity
6. Pharmacist initials
Label requirements for unit-of-use packages in institutional facility?
1. Drug name
2. Strength
3. Control and/or expiration date
Labeling requirements for patients being discharged from institutions?
1. Name, address, and phone number of institutional pharmacy
2. Patient's name
3. Date and identifying serial #
4. Name of drug and strength
5. Directions for use
7. Name of prescriber
8. Precautionary information
Which pharmacies can dispense prescriptions for a patient being discharged?
Only pharmacies with a category III permit, not most institutional pharmacies because they have a category II permit
Requirements for self-administering medications in an institution?
1. Authorized by physician
2. No risk of harm to the patient
3. Patient has received training or has been evaluated to self-administer
What is required for an institution to permit the use of a patient's OWN medications?
1. Patient or representative can maintain the medication at the bedside unless it requires special storage
2. Nurse in charge of the patient's care must witness the administration and keep record of use
If a patient is using their own medication and expires, what is done with the drugs?
They are delivered to the pharmacy for appropriate destruction.
- Cannot be given to the family
- The patient must be aware of this prior to using their own medication.
How long does a patient have to pick up their OWN medication if left at the institution after discharge?
No more than 7 days
Electronic data processing of prescriptions applies to which pharmacies?
Only pharmacies with a category I or category III permit
ISO class 5 atmospheric environment, which contains less than 100 particles five tenths microns in diameter per cubic foot of air?
Class 100 environment
ISO?
International Organization for Standardization
NSF?
National sanitation foundation
Definition of hazardous?
A drug or waste that may be:
1. Cytotoxic
2. Genotoxic
3. Oncogenic
4. Mutagenic
5. Teratogenic
What is a "sterile pharmaceutical?
Free from living microbes and free from chemical or physical contamination
An environmental control device should be capable of maintaining at least what ISO class?
At least ISO class 5 (class 100)
Which ISO class should be maintained in the buffer area?
At least ISO class 8 (class 100,000) conditions in the buffer area
Which references shall be included in the library of preparing sterile preparations?
1. Handbook on injectable drugs
2. The King's guide
3. Another board approved printed or electronic database
What is required if preparing or handling hazardous drugs?
A current copy of "occupational safety and health administration requirements" (OSHA)
Anyone preparing sterile pharmaceuticals must be trained in these areas?
1. Principles of aseptic technique
2. Quality assurance
Requirements for labeling of sterile products?
1. Date of preparation
2. Expiration date
3. Who prepared the preparation
4. Who checked the preparation
5. Patient's name +/- Bed number
6. Name of each drug, along with the strength and quantity
Labeling requirements for sterile products for patients residing at home or outside the facility?
1. Rx#
2. Prescriber's full name
3. Name, address, phone number of the pharmacy
4. Directions for use (including infusion rate and date/time of the administration)
All hazardous drugs shall be compounded in?
A class II, biological safety cabinet
Certification for all biological safety cabinets and class 100 environments shall be performed every?
Six months
The following can satisfy an offer to counsel?
1. Pharmacist counseling patient
2. Intern/extern permitted by the pharmacist and followed by an offer for the pharmacist
3. A written notice containing pharmacy's phone number and bona fide offer when patient is not present or drug/device delivered mail
Documentation requirements for declining counseling?
Must be documented in either written or electronic format and maintained for at least 2 years
Who are exempt from counseling requirements?
Patients in institutions
Security features for control substance prescriptions?
1. Latent, repetitive "void" pattern screened at 5% in reflex blue must appear across entire face of document when prescription is photocopied
2. Custom artificial watermark on back side seen at 45 degree angle consisting of the words "Indiana security pr
Can a pharmacy technician receive verbal orders from the prescriber?
NO, other than refill approval or denial
Can a pharmacy technician answer questions about a patient if talking to a practitioner?
NO, they cannot share information about a patient's profile or prescriptions
A change or an exception to a rule or regulation?
Temporary variance
How is a request for a temporary variance requested?
- Must be submitted to the board in writing with:
1. Detail explanation on the purpose
2. The impact of the variance
How long can variances be granted for? Can they be renewed?
1. For a period of 6 months
2. Can be renewed up to 5 more times
What is a central repository?
A prescription drug monitoring program
What is the PDMP in Indiana?
INSPECT (Indiana scheduled prescription electronic collection and tracking)
What information is submitted to INSPECT? When does it have to be submitted?
1. Prescriptions dispensed for ephedrine, pseudoephedrine, and control substances
2. Within 24 hours of dispensing or by the end of the next business day
Appropriate forms of ID?
1. Valid driver's license issued by IN or any state
2. Valid military ID
3. Valid ID issued by a state's BMV (State ID)
4. Valid photo exempt ID issued by a state's BMV
For the sale of CVs without a prescription, no more than?
1. 240 ml (8 oz) or 48 dosage units of a substance containing opium in any 48 hour period
2. 120 ml (4 oz) or 24 dosage units of any other substance in any 48 hour period
What is the age required for CV substances without a prescription?
- At least 18 years old
- Cannot get more than the max amount for 48 hours
What is the age requirement for buying a syringe OTC?
No age limit
- Sold only by the pharmacist or pharmacy intern
What information is required for CV substances without a prescription or a syringe?
1. Name and address of purchaser
2. Name and quantity of CS or device
3. Date of purchase
4. Name or initials of pharmacist dispensing to purchaser
What must the drug take back programs do with the drugs?
They must destroy the drugs
What is an automated medication system?
Utilizes automation technology to:
1. Store
2. Package
3. Dispense
4. Distribute medications
Not an automatic counting device
How often should the automated medication system be inspected?
Monthly for security and accountability
- Responsibility of the qualifying pharmacist or physician.
What are adjustments a pharmacist can make to a drug regimen?
1. Changes the duration of treatment
2. Adjusts a drug's strength, dosage form, frequency of administration or route of administration
3. Discontinues the use of a drug
4. Adds a drug to the regimen
Drug regimen review committee?
1. Medical director
2. Director of nursing
3. Consultant pharmacist
A modification to a written protocol requires the initiation of a new protocol except for?
Addition or deletion of authorized physicians and pharmacist
Protocols in health facility's must be reviewed by drug regimen committee how often?
At least quarterly
When should the pharmacist notify attending physician when adjusting a patient's therapy within protocol?
At least one business day before the adjustment is made
In order to dispense an overdose medication, what must the pharmacist do?
1. Educate the individual on overdose response and treatment (including administration of the drug)
2. Instruct the individual to call emergency services immediately before or after administering the drug
3. Need to provide information on drug treatment p
Who can sell ephedrine or pseudoephedrine?
A pharmacy or NPLEx retailer ( National Precursor Log Exchange)
What are the requirements to sell pseudoephedrine/ephedrine?
1. Those over 18 years old
2. Does not sell beyond the max limit of:
- 3.6 g in 1 day
- 7.2 g in 30 days
- 61.2 g in 365 days
In regards to the records kept for pseudoephedrine, what must be recorded, and how long must it be kept?
Record the following:
1. The purchaser used a valid government issued ID showing the DOB
2. The purchaser signed a written or electronic log attesting to the validity of information
3. The clerk who is ringing the patient up has to initial or electronical
Members of the BOP are appointed to how many year terms?
Four year terms
A pharmacist intern or pharmacy student may administer immunizations under the supervision of?
1. Pharmacist
2. Physician
3. Physician assistant
4. Advance practice nurse
Performs duties to assist a pharmacist in activities that DO NOT require the professional judgement of a pharmacist?
Pharmacy technician
Pharmacy technician requirements?
1. Not been convicted of a crime that has direct bearing on ability to work
2. Education
3. Approved training program with 12 months of hire OR completion of BOP certification exam
Pharmacy technician training record requirements?
1. Name of technician
2. Start date
3. Start date of training program
4. Date of completion of program
5. Copy of training program
Identification requirements for pharmacists and technicians?
1. Wear identification
2. Identify him/herself in any telephonic or electronic communication
3. Permits and licenses displayed in pharmacy where they can readily be seen by patients
When does a pharmacy permit expire?
Biennially
Oral refill authorization requirements?
1. Date of authorization
2. Number of dose units or quantity authorized
3. Number of additional refills
4. Initials of pharmacist receiving authorization